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Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI guided biopsy
TRUS biopsy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring TRUS biopsy, Pelvic MRI

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer

Inclusion criteria for sub-group follow-up scans:

1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)

Exclusion Criteria:

  • Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
  • The presence of an implanted pacemaker or implanted defibrillator device.
  • Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
  • Implanted medical device not described above that is not MRI-compatible;
  • Known history of severe claustrophobia;
  • For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) < 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed;
  • Minors will be excluded.
  • Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MRI guided biopsy + TRUS biopsy

    Arm Description

    Patients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer

    Outcomes

    Primary Outcome Measures

    Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
    Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
    Number of patients with true diagnosis based on biopsy pathology
    1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant

    Secondary Outcome Measures

    biopsy and MRI based diagnosis match in at least 8/10 patients
    The score based on the true diagnosis and most likely diagnosis as agreed on by classifiers is the same in at least 80% of patients
    Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy
    The diagnostic performance of MRI guided biopsy techniques will be compared with standard TRUS biopsy using a single sample of patients undergoing both biopsy techniques. It has been reported that MRI consistently detects a larger number of clinically significant prostate cancers (sensitivity - 0.91 for MRI-guided biopsy vs 0.76 for TRUS biopsy), while avoiding the detection of cancers that are clinically insignificant, as compared to TRUS biopsy.

    Full Information

    First Posted
    April 17, 2017
    Last Updated
    March 15, 2023
    Sponsor
    Case Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03122470
    Brief Title
    Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer
    Official Title
    Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI departure - study not conducted.
    Study Start Date
    August 1, 2017 (Actual)
    Primary Completion Date
    May 20, 2019 (Actual)
    Study Completion Date
    June 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
    Detailed Description
    The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are: To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer. To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer. To correlate prostate MRI findings and biopsy results with patient progress and outcomes. To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance. Secondary Objectives: To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer. To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes. To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    TRUS biopsy, Pelvic MRI

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MRI guided biopsy + TRUS biopsy
    Arm Type
    Experimental
    Arm Description
    Patients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer
    Intervention Type
    Device
    Intervention Name(s)
    MRI guided biopsy
    Other Intervention Name(s)
    Prostate MRI, Pelvic MRI
    Intervention Description
    The MRI guided biopsy will preferentially be performed using a 3 tesla (3T) Siemens Verio, or 3T Siemens Skyra machine. The multiparametric MRI exam will consist of T1-, T2- and diffusion weighted imaging with or without post-contrast perfusion studies. magnetic resonance fingerprinting (MRF) will be performed before contrast injection. The MRI will be interpreted by two specified radiologists from the research team.
    Intervention Type
    Procedure
    Intervention Name(s)
    TRUS biopsy
    Other Intervention Name(s)
    Prostate Biopsy
    Intervention Description
    The TRUS biopsy will be performed per current standard of care. Biopsy cores will be sent to pathology in separately labeled specimen cups. The final pathological results will be compared with pre-biopsy MRI findings.
    Primary Outcome Measure Information:
    Title
    Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
    Description
    Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
    Time Frame
    Up to two weeks after MRI
    Title
    Number of patients with true diagnosis based on biopsy pathology
    Description
    1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
    Time Frame
    Up to two weeks after MRI
    Secondary Outcome Measure Information:
    Title
    biopsy and MRI based diagnosis match in at least 8/10 patients
    Description
    The score based on the true diagnosis and most likely diagnosis as agreed on by classifiers is the same in at least 80% of patients
    Time Frame
    Up to two weeks after MRI
    Title
    Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy
    Description
    The diagnostic performance of MRI guided biopsy techniques will be compared with standard TRUS biopsy using a single sample of patients undergoing both biopsy techniques. It has been reported that MRI consistently detects a larger number of clinically significant prostate cancers (sensitivity - 0.91 for MRI-guided biopsy vs 0.76 for TRUS biopsy), while avoiding the detection of cancers that are clinically insignificant, as compared to TRUS biopsy.
    Time Frame
    Up to two weeks after MRI

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer Inclusion criteria for sub-group follow-up scans: 1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy) Exclusion Criteria: Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips. The presence of an implanted pacemaker or implanted defibrillator device. Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient. Implanted medical device not described above that is not MRI-compatible; Known history of severe claustrophobia; For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) < 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed; Minors will be excluded. Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lee Ponsky, MD
    Organizational Affiliation
    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer

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